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Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion (OECD 404): not irritating

Eye irritation: (OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 - 22 May 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2015
Deviations:
yes
Remarks:
no rationale for in vivo testing, no initial testing (at first only one animal)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino rabbit, Chbb: NZW (SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, Biberach, Germany
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: commercial diet (ssniff K-H (V2333)), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 - 10 May 1996
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
about 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 square cm.
Vehicle:
other: Polyethylenglycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g, pasted with 0.5 ml Polyethylenglycol 400
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal region
The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

OBSERVATION TIME POINTS
30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches

SCORING SYSTEM:
- Method of calculation: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
No signs of irritation were observed during the whole study.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 May - 12 Jun 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
no rationale for in vivo testing, no initial testing with one animal, no topical anesthetics
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino rabbit, Chbb: NZW (SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, Biberach, Germany
- Weight at study initiation: 2.1 - 3.9 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: commercial (ssniff K-H (V2333)), ad libitum and hay (approx. 15 g daily)
- Water: from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 - 31 May 1996
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg of the unchanged test substance was applied once to the conjunctival sac of the left eye.
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein sodium solution.
Details on study design:
REMOVAL OF TEST SUBSTANCE
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used.
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Remarks:
individual mean after
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
No signs of irritation were observed during the whole study.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation – in vivo

The skin irritation potential of Fatty acids C16-18(even numbered), oligoesters with sucrose was assessed in an in vivo skin irritation study in albino rabbits performed according to OECD Guideline 404 under GLP conditions (key study, 1996). An amount of 0.5 g of the test substance pasted with 0.5 mL Polyethylenglycol 400 was applied to the skin of 3 rabbits under semi-occlusive conditions for 4 hours of exposure. After the exposure period the patch was removed and residual test material was removed with warm tap water. Scores were recorded 0.5-1, 24, 48 and 72 hours after patch removal using the Draize scoring system. No signs of skin irritation were seen in any of the animals. The individual mean erythema and oedema scores over 24, 48 and 72 hours were 0.0 for each animal. Based on the study results, the test substance was considered as not irritating to the skin.

Eye irritation - in vivo

The eye irritation potential of Fatty acids C16-18(even numbered), oligoesters with sucrose was assessed in an in vivo study with 3 albino rabbits performed according to OECD Guideline 405 under GLP conditions (key study, 1996). An amount of 100 mg of the test substance was placed into the conjunctival sac of one eye of each animal. The other eye served as untreated control. Eye irritation scores were recorded at 1, 24, 48, 72 hours and 7 days after instillation using the Draize scoring system. No signs of eye irritation were found. Individual mean cornea opacity, iris, conjunctivae and chemosis scores over 24, 48 and 72 hours were 0.0 for all three animals. Based on the study results, the test substance was considered as not irritating to the eye.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.